EMA Backs Acalabrutinib for Orphan Status in 3 Indications

March 2, 2016

The European Medicines Agency has endorsed Acerta’s acalabrutinib for orphan drug status for the treatment of chronic lymphocytic leukemia, mantle cell lymphoma and lymphoplasmacytic lymphoma. The drug is a BTK inhibitor in Phase 2/3 trials for all three indications.

AstraZeneca purchased a majority stake in Acerta for $4 billion in December, and analysts viewed the orphan announcement as an endorsement of AZ’s decision to invest in the company.